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    Summary
    EudraCT Number:2021-001058-73
    Sponsor's Protocol Code Number:BEY-RAP.V1.0
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-04-07
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedCzechia - SUKL
    A.2EudraCT number2021-001058-73
    A.3Full title of the trial
    Brolucizumab vs. Aflibercept for Retinal Angiomatous Proliferation - Prospective
    Randomised Study
    Brolucizumab vs. aflibercept pro retinální angiomatózní proliferaci – prospektivní randomizovaná studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of brolucizumab and aflibercept in retinal angiomatous proliferation form of wet age related macular degeneration - prospective randomised study
    Srovnání brolucizumabu a afliberceptu v terapii retinální angiomatózní proliferace - varianty vlhké formy věkem podmíněné makulární degenerace
    A.3.2Name or abbreviated title of the trial where available
    Brolucizumab vs. Aflibercept for Retinal Angiomatous Proliferation
    Brolucizumab vs. aflibercept pro retinální angiomatózní proliferaci
    A.4.1Sponsor's protocol code numberBEY-RAP.V1.0
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04698850
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorFakultní nemocnice Královské Vinohrady
    B.1.3.4CountryCzechia
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportFakultní nemocnice Královské Vinohrady
    B.4.2CountryCzechia
    B.4.1Name of organisation providing supportFakultní nemocnice Hradec Králové
    B.4.2CountryCzechia
    B.4.1Name of organisation providing supportFakultní nemocnice Ostrava
    B.4.2CountryCzechia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFakultní nemocnice Královské Vinohrady
    B.5.2Functional name of contact pointMartin Penčák
    B.5.3 Address:
    B.5.3.1Street AddressŠrobárova 1150/50
    B.5.3.2Town/ cityPraha
    B.5.3.3Post code100 34
    B.5.3.4CountryCzechia
    B.5.4Telephone number+420775026041
    B.5.6E-mailpencak@volny.cz
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Beovu
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationCzechia
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravitreal use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Eylea
    D.2.1.1.2Name of the Marketing Authorisation holderBayer AG
    D.2.1.2Country which granted the Marketing AuthorisationCzechia
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravitreal use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Retinal angiomatous proliferation form of neovascular age related macular degeneration (AMD).
    Renitální angiomatózní proliferace - varianta vlhké formy věkem podmínění makulární degenerace (VPMD).
    E.1.1.1Medical condition in easily understood language
    Retinal angiomatous proliferation is a form of neovascular AMD - an eye disease that worsens the vision due to abnormal blood vessels that leak fluid or blood into retina.
    Retinální angiomatózní proliferace je variantou neovaskulární formy VPMD - onemocnění oka, které zhoršuje vidění vlivem abnormálních krevních cév, které prosakují tekutinu nebo krev do sítnice.
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the change in best corrected visual acuity (BCVA), central retinal thickness (CRT) on OCT
    and number of injections in patients with retinal angiomatous proliferation (RAP) treated with brolucizumab and aflibercept.
    Srovnat změnu nejlepší korigované zrakové ostrosti (NKZO), centrální retinální tloušťku (CRT) na OCT a počet injekcí u pacientů s retinální angiomatózní proliferací (RAP) léčených brolucizumabem a afliberceptem.
    E.2.2Secondary objectives of the trial
    To compare the number of patients without any intra- or subretinal fluid and PED on the OCT, number of patients who gained more than 15 ETDRS letters in each group, number of patients who lost more than 15 ETDRS letters in each group, number of drug or procedure related adverse events, such as uveitis, retinal breaks, intraocular haemorrhage etc. and number of patients who received rescue therapy in each group.
    Srovnat počet pacientů bez intraretinální a subretinální tekutiny a ablace pigmentového listu sítnice (PED) na OCT, počet pacientů se ziskem > 15 písmen ETDRS, počet pacientů se ztrátou > 15 písmen ETDRS, výskyt nežádoucích účinků spojených se studijní medikací nebo procedurou jako je uveitida, trhliny sítnice, intraokulární hemoragie atd., a procento pacientů, u kterých bylo nutné podat záchrannou terapii mezi oběma skupinami.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. age of 50 years or more at the time the informed consent is signed
    2. active RAP in the macula including fovea diagnosed on OCT and OCT angiography (OCTa)
    3. BCVA between 70 to 35 ETDRS letters (approx. 20/40 to 20/200 Snellen
    equivalent) in the study eye
    4. decrease in BCVA caused primarily by the RAP in the study eye
    5. presence of intra- or subretinal fluid or PED in the central 1 mm of the
    macula on the OCT
    6. patient capable of signing the informed consent
    1. Věk nejméně 50 let v době podpisu informovaného souhlasu
    2. Aktivní RAP v makule postihující foveou diagnostikovaná na OCT a OCT angiografii (OCTa)
    3. NKZO v rozmezí od 70 do 35 písmen EDTRS optopytů (odpovídající přibližně skóre 20/40 až 20/200 podle Snellena) na studijním oku
    4. Snížení NKZO stanovené primárně jako důsledek RAP v hodnoceném oku
    5. Přítomnost intraretinální nebo subretinální tekutiny nebo PED postihující centrální část sítnice v hodnoceném oku zjištěná pomocí OCT. Centrální část sítnice je definována jako kruh o průměru 1 mm v centru fovey
    6. Pacient schopný podepsat informovaný souhlas
    E.4Principal exclusion criteria
    1. other causes of choroidal neovascular membrane (CNV) than wAMD
    2. previous or current conditions of the study eye:
    a. subretinal haemorrhage comprising more than 25% of the lesion in the study eye
    b. scar or fibrosis comprising more than 50% of the lesion in the study eye
    c. presence of retinal pigment epithelium (RPE) tears or ruptures in the central 1 mm of the macula in the study eye
    d. total lesion size more than 8 papillary diameters (PD) as per OCT and FP examination
    e. uncontrolled glaucoma in the study eye defined as IOP of more than 25 mmHg despite the antiglaucoma treatment
    f. idiopathic or autoimmune uveitis in the study eye
    g. other pathologies in the macula of the study eye which can be expected to influence the BCVA (e.g. macular hole, retinal atrophy, epiretinal membrane, etc.)
    h. history of glaucoma surgery in the study eye or probability that it will be necessary in the future
    i. aphakia or pseudophakia with absence of the posterior lens capsule (with the exception of missing posterior capsule due to Nd:YAG laser capsulotomy) in the study eye
    j. myopia in the study eye with spherical equivalent of more than 8 dioptries before any refractive or cataract surgery
    k. significant opacities of the ocular media in the study eye including cataract, which can interfere with BCVA assessment or FP or OCT examination
    l. corneal transplantation or corneal dystrophy in the study eye
    m. irregular astigmatism or BCVA-lowering amblyopia in the study eye
    n. diabetic retinopathy, diabetic macular edema or any other retinal
    vascular disease in the study eye
    o. extraocular or periocular infection or inflammation (e.g. blepharitis,
    keratitis, conjunctivitis, scleritis, etc.) in any eye at the time of
    screening or baseline visit
    p. any intraocular infection or inflammation in any eye during 12 weeks (84 days) before the screening visit
    q. previous treatment with intravitreal or periocular antiVEGF or corticosteroids in the study eye
    r. treatment with systemic intravenous antiVEGF or corticosteroids during 12 weeks (84 days) before the screening visit
    3. allergy or hypersensitivity to any component contained in the study
    drug
    4. pregnant or breastfeeding women
    1. Příčiny CNV v hodnoceném oku jiné než VPMD.
    2. Předchozí nebo souběžné stavy v hodnoceném oku:
    a. v hodnoceném oku subretinální hemoragie, která zasahuje nejméně 25 % celkové plochy léze
    b. jizva nebo fibróza tvořící více než 50 % celkové plochy léze v hodnoceném oku
    c. přítomnost trhlin nebo prasklin v retinálním pigmentovém epitelu, které zahrnují centrální část sítnice hodnoceného oka
    d. v hodnoceném oku celková velikost léze > 8 ploch optického disku při posouzení pomocí OCT a fotografie fundu
    e. v hodnoceném oku nekompenzovaný glaukom (definováno jako IOP >25 mmHg navzdory užívání antiglaukomové léčby)
    f. idiopatická nebo autoimunitní uveitida v hodnoceném oku v anamnéze
    g. jiná onemocnění makuly na hodnoceném oku prokázané biomikroskopicky nebo pomocí OCT, o kterých lze předpokládat, že ovlivňují centrální vidění (makulární díra, vitreomakulární trakce, epiretinální membrána, atrofie apod.)
    h. antiglaukomový zákrok na hodnoceném oku v anamnéze, nebo pravděpodobnost, že bude tento zákrok v budoucnosti nezbytný
    i. afakie nebo pseudofakie s absencí zadního pouzdra v hodnoceném oku (pokud k ní nedošlo v důsledku zadní kapsulotomie provedené pomocí YAG laseru)
    j. myopie v hodnoceném oku se sférickým ekvivalentem > 8 dioptrií před provedením jakékoliv refrakční operace nebo operace katarakty
    k. významné opacity očních médií hodnoceného oka, včetně katarakty, které interferují s hodnocením BCVA, snímkování fundu nebo zobrazováním pomocí OCT
    l. transplantace nebo dystrofie rohovky v hodnoceném oku v anamnéze
    m. nepravidelný astigmatismus nebo amblyopie s chronickým omezením BCVA hodnoceného oka v anamnéze
    n. diabetická retinopatie, diabetický makulární edém nebo jakékoli vaskulární onemocnění retiny jiné než VPMD ve studijním oku v anamnéze nebo klinicky prokázané v současnosti
    o. prokázaná extraokulární nebo periokulární infekce nebo zánět (zahrnující infekční blefaritidu, keratitidu, skleritidu nebo konjunktivitidu) v kterémkoli oku v době screeningu/randomizace
    p. jakýkoliv/jakákoliv intraokulární zánět/infekce v kterémkoli oku během 12 týdnů (84 dnů) před screeningovou návštěvou
    q. předchozí léčba studijního oka intravitreálním nebo periokulárním podáním antiVEGF preparátů nebo kortikoidů
    r. systémová intravenózní léčba antiVEGF preparáty nebo kortikoidy během 12 týdnů (84 dnů) před screeningovou návštěvou
    3. alergie nebo hypersenzitivita na jakoukoli složku / pomocnou látku obsaženou v hodnocených intervenčních léčivých přípravcích.
    4. těhotné a kojící ženy
    E.5 End points
    E.5.1Primary end point(s)
    1. Best corrected visual acuity (BCVA)
    BCVA change from baseline to week 52 in ETDRS letters.
    2. Central retinal thickness (CRT)
    CRT change on OCT from baseline to week 52.
    3. Number of injections
    Average number of injections per patient in each group.
    1. Nejlepší korigovaná zraková ostrost (NKZO)
    Změna NKZO mezi vstupní návštěvou a týdnem 52 v písmenech ETDRS optotypů.
    2. Centrální retinální tloušťka (CRT)
    Změna CRT na OCT mezi vstupní návštěvou a týdnem 52
    3. Počet injekcí
    Průměrný počet injekcí na pacienta v každé skupině.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52
    Týden 52
    E.5.2Secondary end point(s)
    4. Dry macula
    Number of patients without any intra- or subretinal fluid and pigment epithelium detachment (PED) on the OCT examination at week 52.
    5. Significant visual gain
    Number of patients who gained more than 15 ETDRS letters in each group.
    6. Significant visual loss
    Number of patients who lost more than 15 ETDRS letters in each group.
    7. Adverse events
    Number of drug or procedure related adverse events, such as uveitis, retinal breaks, intraocular haemorrhage etc.
    8. Rescue
    Number of patients who received rescue therapy in each group.
    4. Suchá makula
    Počet pacientů bez intraretinální a subretinální tekutiny a ablace pigmentového listu sítnice (PED) na v každé skupině
    5. Významné zlepšení vidění
    Počet pacientů se ziskem více než 15 písmen ETDRS v každé skupině.
    6. Významný pokles vidění
    Počet pacientů se ztrátou více než 15 písmen ETDRS v každé skupině.
    7. Nežádoucí účinky
    Počet nežádoucích účinků spojených se studijní medikací nebo procedurou, jako je uveitida, trhliny sítnice, intraokulární hemoragie, apod.
    8. Záchrana
    Počet pacientů, u kterých bylo nutné podat záchrannou terapii v každé skupině.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 52
    Týden 52
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    Poslední návštěva posledního subjektu
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Žádné
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-06-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-23
    P. End of Trial
    P.End of Trial StatusOngoing
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